(432 days)
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.
The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.
Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.
Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.
Here's an breakdown of the information present and what's missing, based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance:
- Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
- Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
- Cytotoxicity testing (per ISO 10993-5 and USP <87>): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
- Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
- LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP <85>, <161>): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
- Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
- Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.
2. Sample sized used for the test set and the data provenance:
- Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
- Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable to the presented data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
- Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.
8. The sample size for the training set:
- Missing: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Missing: Not applicable.
In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 30, 2018
Zuga Medical, Inc. Chan Wang, CEO 24400 Chagrin Blvd. Suite 250 Beachwood, Ohio 44122
Re: K171197
Trade/Device Name: Zuga™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 25, 2018 Received: June 1, 2018
Dear Chan Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7. Indications for Use Statement
510(k) Number: _K171197
Device Name: Zuga™ Dental Implant System
Indications for Use:
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary K171197
| Date: | 29 June 2018 |
|---|---|
| Sponsor: | Zuga Medical, Inc.24400 Chagrin BoulevardSuite 250Beachwood, OH 44122Phone: 216.282.5910Facsimile: 1.855.438.9842 |
| Contact Person: | Chan Wang, CEO |
| Trade Names: | Zuga™ Dental Implant System |
| Device Classification: | Class II |
| Classification Name: | Implant, endosseous, root-form & abutment, implant, dental,endosseous |
| Regulation: | 872.3640 |
| Device Product: | DZE & NHA |
| Device Description: | The Zuga™ Dental Implant System includes endosseous dentalimplants, sealing caps, healing caps, dental implant abutments,and fixation screws in a variety of sizes to accommodate differingpatient anatomy. Implantation is suitable for one-or two-stageprocedures.Endosseous implants are bone level, self-tapping, root-form,threaded. The threaded surface is blasted, then passivated.Sizematched anterior and posterior abutments are offered. Thesare fastened to the implant using a fixation screw. Sealing capsand healing caps provide protection to the abutment connectionthreads during endosseous and gingival healing.The implants are provided sterile, the remaining componentsmust be sterilized prior to use. |
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| Implant | Material | Cold Worked Ti Grade 4 as described in ASTM F67 |
|---|---|---|
| Diameter (mm) | 3.5, 4.3, 5.0 | |
| Length (mm) | 8.00, 9.00, 10.00, 11.00, 12.00,13.00, 14.00, 15.00, 16.00, 17.00 | |
| Angulation | - | |
| Description | Endosseous Implant | |
| Ti Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 |
| Diameter (mm) | 4.75, 5.50, 6.25, 7.00 | |
| Post Height (mm) | 4.00, 5.50, 7.00 | |
| Angulation | - | |
| Description | Straight Titanium Abutment | |
| Angled Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67or Cold Worked Ti Grade 5 |
| Diameter (mm) | 3.5, 4.3, 5.0 | |
| Post Height (mm) | 8.50, 9.50, 10.50, 11.50 | |
| Angulation | 15, 25 | |
| Description | Angled Titanium Abutment | |
| Ball Abutment | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| Diameter (mm) | 3.5 | |
| Gum Height (mm) | 1.00, 2.00, 3.00, 4.00, 5.00 | |
| Angulation | - | |
| Description | Abutment for overdenture restoration | |
| Removable DentureAbutment | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| Diameter (mm) | 3.85 | |
| Gum Height (mm) | 1.00, 2.00. 3.00, 4.00, 5.00 | |
| Angulation | - | |
| Description | Abutment for overdenture restoration | |
| Hybrid Abutment | Material | ZIY and Cold Worked Ti Grade 4 as described inASTM F67 |
| Diameter (mm) | 4.25, 4.30, 5.05, 5.50 | |
| Length (mm) | 10.50 | |
| Angulation | - | |
| Description | Titanium and Zirconium abutment | |
| Multi-Unit Abutment | Material | Cold Worked Ti Grade 4 as described in ASTM F67 |
| Diameter (mm) | 4.00, 4.80 | |
| Gum Height(mm) | 1.50, 2.50, 3.50, 4.50 | |
| Angulation | 0, 17, 30 | |
| Description | Titanium Abutment to be used with multipleprosthetic devices | |
| Healing Cap | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| Diameter (mm) | 4.85, 5.65, 6.35 | |
| Post Height(mm) | 3.00, 5.00, 7.00 | |
| Angulation | - | |
| Description | Protects implant during healing. | |
| Fixation Screw | Material | Titanium 6AL-4V per ASTM F136 |
| Diameter (mm) | 2.35 | |
| Length (mm) | 7.50 | |
| Angulation | - | |
| Description | Fastens abutment to implant | |
| Sealing Cap | Material | Titanium CP Grade 4 Cold Worked or Annealed |
| Diameter (mm) | 2.75 | |
| Length (mm) | 5.00 | |
| Angulation | - | |
| Description | Protects implant during healing. |
Zuga Medical is making no claims regarding pyrogenicity.
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| Indications for Use: | The Zuga™ Dental Implant System is indicated for immediate ordelayed implant placement for surgical and restorativeapplications in maxillary and/or mandibular arches to supportprosthetic devices, such as artificial teeth, crowns, bridges andoverdentures. The Zuga™ Dental Implant System is indicated forimmediate loading when good primary stability is achieved andwith appropriate occlusal loading. |
|---|---|
| Predicate Devices: | Zuga™ Dental Implant System - K122664T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System –K152787OCO Biomedical Fixed Solid O-Ball Abutment – K090174Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570Reliadent Dental Implant System - K043428, K061323Biomet 3i Certain System – K0100724KAT Implants System Implants, KAT Implants System ImplantAbutment – K083544KAT Implants System Implants, KAT Implants System StraightAbutments – K101201Southern Implants Endosseous Dental Implant System –K070841, K071161 |
| TechnologicalCharacteristics: | The fundamental scientific technology of the Zuga™Dental Implant System is the same as previously cleared devicesas shown below, (i.e. the Zuga design features are common toone or more of the predicates). |
| Zuga Implant System | ||||||
|---|---|---|---|---|---|---|
| Subject Device | PrimaryPredicateDevice | Reference Devices | ||||
| Company | Zuga Medical | Zuga Medical | Reliadent | Biomet 3i | KAT | SouthernImplants |
| 510(k) Number | New Device | K122664 | K043428,K061323 | K100724 | K083544,K101201 | K070841,K071161 |
{7}------------------------------------------------
| KAT ImplantSystemDentalImplants areindicated forrestoration ofedentulousmaxilla andmandible, toprovidesupport forremovabledentures,fixed bridges,or to be usedas a singletoothreplacement.Single orsplintedimplants canbeimmediatelyloaded ifgood primarystability andappropriateocclusalloading areachieved.The implantscan beplaced inextractionsites orhealedalveolarridges.Immediateloading maynot beappropriatein Type IVbone due todifficulty inachievingPrimarystability | The NSIImplantSystem isintended to beimplanted inthe upper orlower jawarches toprovidesupport forfixed orremovabledentalprostheses in asingle tooth,partiallyedentulousprostheses, orfull archprostheses. Itfurther addsthe option forimmediateloading onsingle andsplintedmultiple unitrestorationswhen goodprimarystability isachieved andwithappropriateocclusalloading, torestorechewingfunction. | |||||
|---|---|---|---|---|---|---|
| Intended Use | The Zuga™Dental ImplantSystem isindicated forimmediate ordelayed implantplacement forsurgical andrestorativeapplications inmaxillary and/ormandibulararches tosupportprostheticdevices, such asartificial teeth,crowns, bridges,andoverdentures.The Zuga™Dental ImplantSystem isindicated forimmediateloading whengood primarystability isachieved andwith appropriateocclusal loading. | The Zuga™Dental ImplantSystem isindicated forimmediate ordelayed implantplacement forsurgical andrestorativeapplications inmaxillary and/ormandibulararches tosupportprostheticdevices, such asartificial teeth,crowns, bridges,andoverdentures.The Zuga™Dental ImplantSystem isindicated forimmediateloading whengood primarystability isachieved andwith appropriateocclusal loading. | The ReliadentDental ImplantSystem isindicated forimmediate ordelayed surgicaland restorativeapplication forplacement inmaxillary and /ormandibulararches tosupportprostheticdevices, such asartificial teeth,crowns, bridgesandoverdentures forthe patient. | BIOMET 3iDentalImplants areintended forsurgicalplacement ineither jaw andused foranchoring orsupportingsingle- andmultiple-unitprostheses.BIOMET 3iDentalImplants canbeimmediatelyloaded whenprimarystability andproperocclusion havebeenestablished. |
{8}------------------------------------------------
| Material ofManufacture: | Titanium,Titanium Alloy | Titanium,Titanium Alloy | Titanium | Titanium,Titanium Alloy | TitaniumAlloy | Titanium |
|---|---|---|---|---|---|---|
| Endosseous Implant | ||||||
| Endosseous ImplantDesign | Root-form,Straight andtapered | Root-form,Straight | Root-form,Straight | Root-form,Straight andtapered | Root-form,Straight andtapered | Root-form,Straight andtapered |
| Method ofstabilization | Threadedfixation | Threadedfixation | Threadedfixation | Threadedfixation | Threadedfixation | Threadedfixation |
| Range of Diameters | 3.5 – 5.5mm | 3.5 – 5.5mm | 3.0 – 5.5mm | 3.25 – 6mm | 2.5 – 8mm | ---- |
| Range of Lengths | 8 – 17 mm | 8 – 17 mm | 8 – 16mm | 8.5 – 20mm | 6 – 14mm | ---- |
| Surface Treatment | Al2O3 blasted,passivated | Al2O3 blasted,passivated | Titaniumblasted andacid etched | acid etched | Al2O3blasted,passivated | Al2O3 blasted |
| Color-coding | Seating surfaceor None | Seating surface | Anodizedseating | Seatingsurface | None | None |
| Sterilization | Sterile,Gammaradiation | Sterile,Gammaradiation | Sterile,Gammaradiation | Sterile,Gammaradiation | Sterile,Radiation | Sterile,Gammaradiation |
| Endosseous Implant Abutment | ||||||
| Abutment Design | Standard | Standard | Standard,Angled | ---- | Standard,Angled | Standard,Angled |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | ---- | Non-sterile | ---- |
| Connection toImplant | Hex alignment,screwattachment | Hex alignment,screwattachment | Hex alignment,screwattachment | ---- | Indexing keyalignment,1.5° lockingtaper, screwattachment | ---- |
| Color-coding | Connectioninterface or none | Connectioninterface | Connectioninterface | ---- | ---- | ---- |
| Angled Abutment | |||
|---|---|---|---|
| Subject Device | Primary PredicateDevices | Reference Device |
{9}------------------------------------------------
| System: | Zuga | T-Plus Implant Tech. Co., Ltd | MegaGen Co., Ltd |
|---|---|---|---|
| Device Name | Zuga Dental Implant System | ST Internal Fixture System | Ex Feel Dental Implant System |
| 510(k) Number | New Device | K152787 | K052369 |
| Intended Use | The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Fixture System is intended for use for immediate loading when good primary stability is acheived and with appropriate occlusal loading. | The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single state surgical procedure. |
| Abutment Diameters, mm | 3.5, 4.3, 5.0 | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Abutment Cuff(Gum) Height, mm | 1.5, 2.5, 3.5, 4.5 | 1.0, 2.0, 3.0, 4.0, 5.0 | 2.0, 4.0 |
| Angulation Range | 15°, 25° | 15°, 25° | 15°, 25° |
| Implant to Abutment Connection | Internal Hexagon | Internal Hex Connection | Internal and External Hex |
| Abutment Fixation | Abutment Screw | - | - |
| Abutment Material | Titanium Alloy | C.P. Titanium and Titanium Alloy | C.P. Titanium and Titanium Alloy |
| Sterilization | Delivered Non-Sterile | Delivered Non-Sterile | Delivered Non-Sterile |
| Reusable | No | No | No |
{10}------------------------------------------------
| Ball Abutment | ||||
|---|---|---|---|---|
| Subject Device | Primary Predicate Device | Reference Devices | ||
| Company | Zuga Medical | OCO Biomedical | Nova Implants Ltd. | SGS International Ltd. |
| Device Name | Zuga DentalImplant System -Ball Abutment | Fixed Solid O-BallAbutment | Ball AttachmentBAT | Overdenture Ball Attachment S3 |
| 510(k) Number | New Device | K090174 | K150363 | K133362 |
| Intended Use | The Zuga™ DentalImplant System isindicated forimmediate ordelayed implantplacement forsurgical andrestorativeapplications inmaxillary and/ormandibular archesto supportprostheticdevices, such asartificial teeth,crowns, bridges,and overdentures.The Zuga™ DentalImplant System isindicated forimmediateloading whengood primarystability isachieved and withappropriateocclusal loading. | The TSI and ERIDental Implants areartificial rootstructuresintended forpermanent surgicalimplantation inthe bone for thepurpose of single ormultiple toothreplacements(splinted or freestanding), or forstabilization of aprosthetic system,such as artificialteeth in order torestore thepatient's chewingfunction. The TSIand ERI can beplaced in theanterior orposteriormandible/maxillafor immediate ordelayed loadingpurposes. | NOVA® DentalImplants System isindicated foruse in surgical andrestorativeapplications forplacement in thebone of the upperor lower jaw toprovide support forprostheticdevices, such asartificial teeth, inorder to restore thepatient'schewing function.NOVA® DentalImplants System isindicated also forimmediateloading whengood primarystability isachieved and withappropriateocclusal loading. | SGS® Dental Implants System isintended for surgical placement in themaxillary and/or mandibular arch tosupport crowns, bridges, oroverdentures in edentulous orpartially edentulous patients. SGS®Dental Implants System may beimmediate loading when goodprimary stability is achieved and withappropriate occlusal loading. |
| Abutment Heights,mm | 1, 2, 3, 4, 5 | 0, 2, 3, 4 | 1, 2, 3, 4, 5 ,6 | 1, 2, 3, 4, 5, 6 |
| Implant toAbutmentConnection | External Square | External Square | Internal Hex | Internal Hex, Overdenture rest. |
| AbutmentFixation | Screw Retained | Screw Retained | Screw Retained | - |
| Abutment Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Sterilization | DeliveredNonSterile | - | - | - |
| Reusable | No | No | No | No |
{11}------------------------------------------------
| Multi-Unit Abutment | ||||
|---|---|---|---|---|
| Subject Device | Primary PredicateDevice | Reference Device | ||
| Company | Zuga Medical | Nobel Biocare AB | Biodenta Swiss AG | Biomet 3i |
| Device Name | Zuga DentalImplant System –Multi-UnitAbutment | NobelActiveMulti-UnitAbutment | Biodenta DentalImplant System-Multi-UseAbutment | Low Profile Abutment |
| 510(k) Number | New Device | K072570 | K123491 | K092341 |
| Intended Use | The Zuga™ DentalImplant System isindicated forimmediate ordelayed implantplacement forsurgical andrestorativeapplications inmaxillary and/ormandibular archesto supportprostheticdevices, such asartificial teeth,crowns, bridges,and overdentures.The Zuga™ DentalImplant System isindicated forimmediate loadingwhengood primarystability is | NobelActiveMulti-UnitAbutment is a pre-manufacturedprostheticcomponent directlyconnected to theendosseousdental implantand is intendedfor use as an aid inprostheticrehabilitation. | Biodenta DentalImplant SystemMulti-UseAbutments areintended forterminal orintermediateabutment supportfor fixed orremovable crown,bridgework, and toretainoverdentures. | Biomet 3i Low Profile Abutments areintended for use as accessoriesto endosseous dental implant tosupport a prosthetic device in apartially or completely edentulouspatient. A dental abutment isintended for use to support singleand multiple tooth prosthesis, in themandible or maxilla. The prosthesisis screw retained to the abutment. |
{12}------------------------------------------------
| achieved and withappropriate occlusalloading. | ||||
|---|---|---|---|---|
| Restorations | Screw Retained | Screw Retained | Screw Retained | Screw Retained |
| Abutment Type | Straight & Angled | Straight & Angled | Straight & Angled | Straight & Angled |
| Abutment Angle | 0°,17°,30° | 0°,17°,30° | 0°,18°,30° | 0°,17°,30° |
| Implant toAbutmentConnection | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| AbutmentFixation | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw |
| 3.5mm | 3.5mm | 3.5mm | 3.25mm | |
| CompatibleImplantsDiameter | 4.0mm | 4.3mm | 4.1mm | 4.0mm |
| 4.3mm | 5.0mm | 4.8mm | 5.0mm | |
| 5.0mm | 6.0mm | |||
| AbutmentCuff(Gum) Height | 1.5-4.5mm (0°) | 1.5-4.5mm (0°) | 2.0-5.0mm (0°) | 1.0-4.0mm (0°) |
| 2.5-3.5mm (17°) | 2.5-3.5mm (17°) | 2.2–5.2mm (18°) | 2.0-4.0mm (17°) | |
| 3.5-4.5mm (30°) | 3.5-4.5mm (30°) | 2.0-5.0mm (30°) | 3.0-5.0mm (30°) | |
| Abutment Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Sterilization | Delivered NonSterile | Delivered NonSterile | Delivered NonSterile | Delivered Non-Sterile |
| Reusable | No | No | No | No |
| Removable Denture Abutment | ||
|---|---|---|
| Subject Device | Primary Predicate Device | |
| Company | Zuga Medical | Zest Anchors, Inc. |
| Device Name | Zuga Dental Implant System -Removable Denture Abutment | LOCATOR Implant Anchor Abutment forEndosseous Dental Implant |
| 510(k) Number | New Device | K072878 |
{13}------------------------------------------------
| Intended Use | The Zuga™ Dental ImplantSystem is indicated forimmediate or delayed implantplacement for surgical andrestorative applications inmaxillary and/or mandibulararches to support prostheticdevices, such as artificial teeth,crowns, bridges, andoverdentures. The Zuga™Dental Implant System isindicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. | The LOCATOR Implant Anchor Abutment forEndosseous Dental Implants is appropriate foruse with overdentures or partial denturesretained in whole or in part by endosseousimplants in the mandible or maxilla. |
|---|---|---|
| Abutment Diameters, mm | 3.85 | 3.25 to 6.5 |
| Abutment Angle | Straight | Straight |
| Abutment/Implant Interface | Screw Retention | Conical, External Hex, Internal Hex, Internal MultiLobe |
| Divergence Allowance | Maximum 40° divergencebetween two implantconstructs, with each individualimplant/abutment constructhaving no more than 20°correction. | 20°/40° |
| Prosthesis Attachment Type | Nylon Male retention cap | Nylon male retention cap |
| Abutment Material | Titanium Grade 4 | Ti-6Al-4V ELI |
| Prosthetic RetentionComponent | Nylon | Nylon |
{14}------------------------------------------------
Hybrid Abutment
| System: | Zuga™ DentalImplantSystem -HybridAbutment | K122664Zuga™ DentalImplantSystem -PrimaryPredicate | K1430112014InterActive/SwishActiveSystem -ReferencePredicate |
|---|---|---|---|
| ENDOSSEOUS IMPLANT ABUTMENT | |||
| Material of Manufacture: | |||
| Abutment | NA | Titanium | NA |
| Abutment Base | Titanium | NA | Titanium |
| Abutment Upper | Yttria-stabilizedZirconia | NA | Yttria-stabilizedZirconia |
| Connection | Cement | NA | Cement |
| Design: | Straight | Straight | Straight,Angled, orModified |
| Sterilization | Non-Sterile | Non-Sterile | Non-Sterile |
| Connected to Implant | Hex alignment,screwattachment | Hex alignment,screwattachment | Hex alignment,screwattachment |
| Implant Platformsit can be used with | 3.5, 4.3, 5.0,5.5 | 3.5, 4.3, 5.0,5.5 | Not known |
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Performance Data: Static fatigue tests and dynamic fatigue tests were performed per ISO 14801 and FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The worst case scenarios for the Zuga™ Dental Implant System were tested. The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application.
Cytotoxicity testing was performed per ISO 10993-5 and The United States Pharmacopeia & National Formulary (USP <87>). The worst case scenarios for the Zuga™ Dental Implant System were tested. The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application.
Sterility tests performed under ISO 10993 yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device. Sterile subject devices were evaluated in accordance to ISO 11137-1 and 11137-2. "End-user" sterilized devices were validated according to ISO 17665-1 and 17665-2.
Further, LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests performed under ISO 10993 on the subject device yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device for medical devices not intended to contact cerebrospinal fluid.
Shelf life tests are performed under ISO 11607 for evaluating seal strength of flexible barrier materials and porous medical packaging used in the sterile packaged products in the Zuga™ Medical Dental Implant System. Test results established the shelf life to be five years provided the sterile seal is not breached. The subject device is a titanium alloy, non-mechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf-life period. Special storage conditions are not required for the device, as ambient storage conditions are not expected to adversely affect the safety or efficacy of the device.
In accordance with the United States Pharmacopeial Convention, Inc. USP <85>, Bacterial Endotoxins Tests (BET), also known as Limulus Amebocyte Lysate (LAL) tests, is made to determine that
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the device meets pyrogenicity limit specifications. These Bacterial Endotoxins Tests (BET) are run in accordance with the kinetic turbidimetric method as follows: Representative samples are selected from each sterilization batch. Each sterilization batch consists of multiple manufacturing lots. The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing. The Testing limit is 20 EU/device because, according to USP ,161> the limit for a device in contact with the circulatory system or lymphatic system is 20 EU/device.
Conclusion: The Zuga™ Dental Implant System device possesses the same intended use and technological characteristics as the predicate devices. This with the information provided in the submission permit the conclusion that the Zuga™ Dental Implant System is substantially equivalent to the predicate devices.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.